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Luminance RED for Canker Sores

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04914533
Recruitment Status : Not yet recruiting
First Posted : June 4, 2021
Last Update Posted : June 4, 2021
Sponsor:
Collaborator:
Luminance RED
Information provided by (Responsible Party):
ProofPilot

Brief Summary:

Canker sores, also called aphthous ulcers, are small, shallow lesions that develop on the soft tissues in your mouth or at the base of your gums. Unlike cold sores, canker sores don't occur on the surface of your lips and they aren't contagious. They can be painful, however, and can make eating and talking difficult. Recurrent aphthous ulcer stomatitis (RAS) is characterized by recurrent bouts of solitary or multiple shallow painful ulcers, at intervals of a few months to a few days in patients who are otherwise well.

Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The light triggers biochemical changes within cells and can be compared to the process of photosynthesis in plants, where the photons are absorbed by cellular photoreceptors, which trigger chemical changes.

The main medical usage of LLLT is for pain and inflammation reduction, promoting the regeneration of different tissues and preventing damage to tissues. With the use of the appropriate power (from 5 to 200mW) and wavelength (600-900nm), the therapy brings anti-inflammatory and analgesic results aiding in wound healing. The mechanism of action of LLLT may be very beneficial in the treatment of oral erosions and ulcers, however, very few studies have been performed on the treatment of RAS with LLLT. There are few reports on accelerated healing in erosive mucocutaneous disorders and they are often presented as a case series rather than large randomized clinical trials. The effects on skin wound healing and periodontal inflammation management with laser biostimulation suggest that this treatment modality may also be useful for oral erosive conditions.

This clinical trial aims to evaluate the effect of the Luminance RED device on the management of RAS.


Condition or disease Intervention/treatment Phase
Canker Sore Device: Luminance RED Low Level Laser Therapy Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Real-world Study Examining the Effect of the Luminance RED Device on Recurrent Aphthous Ulcer Stomatitis
Estimated Study Start Date : June 21, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

Arm Intervention/treatment
Experimental: Intervention Arm
Luminance Red Treatment Arm
Device: Luminance RED Low Level Laser Therapy Device
Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The Luminance RED Device is specifically designed to make it easy to issue LLLT to canker sores.




Primary Outcome Measures :
  1. Change in Visual Analog Pain Scale [ Time Frame: Baseline to day 18 ]
    daily score of canker sore pain

  2. Change in Eating, drinking, and brushing teeth questionnaire [ Time Frame: Baseline to day 18 ]
    score calculated on daily discomfort with eating, drinking and brushing teath


Secondary Outcome Measures :
  1. Device retention [ Time Frame: Day 21 ]
    Percentage of participants who decide to keep device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  • 18 years and older.
  • Self report canker sore outbreaks once every 30 days or more frequent
  • Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • No previous experience of LLLT.
  • United States resident.
  • Willingness and ability to submit a $49 deposit using a credit card for the device.

Exclusion Criteria:

  • Patients with a known systemic disease that predisposes them to RAS (e.g., Behçet disease) or undergoing systemic treatment for RAS.
  • The presence of a serious medical condition.
  • Currently known to be pregnant or breastfeeding
  • Patients treated with topical or systemic medication for RAS, such as corticosteroid therapy, antibiotics or analgesics during the previous month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914533


Contacts
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Contact: Matthew M Amsden (888) 870-4189 crew@proofpilot.com

Locations
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United States, New York
ProofPilot Virtual Online Trial (https://proofpilot.com)
New York, New York, United States, 10003
Sponsors and Collaborators
ProofPilot
Luminance RED
Investigators
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Principal Investigator: Matthew M Amsden ProofPilot
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Responsible Party: ProofPilot
ClinicalTrials.gov Identifier: NCT04914533    
Other Study ID Numbers: 2795
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stomatitis, Aphthous
Stomatitis
Mouth Diseases
Stomatognathic Diseases